Crius PEEK Suture Anchor System (4 models)— 510(k) K243665

Clearance details

Device name as filed

Crius PEEK Suture Anchor System (Thread-Fix Anchor); Crius PEEK Suture Anchor System (Thread-Fix Ultra Anchor); Crius PEEK Suture Anchor System (Helicoil Anchor); Crius PEEK Suture Anchor System (Pile Anchor)

Applicant

ZheJiang Decans Medical Devices Co., Ltd.

Product code

Code MBI

Device class

Class 2

Regulation

21 CFR 888.3040

Advisory panel

Orthopedic

Date received

2024-11-27

Decision date

2025-01-31

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Jiaxing, CN

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• K262047 — Grappler Suture Anchor System2026-08-03
• K262369 — AIR+ All-Inside Meniscal Repair Device, Curved Up; AIR+ All-Inside Meniscal Repair Device, Curved Down2026-07-30

• K253046 — HERA Interlocking Intramedullary Nailing System2026-06-16
• K253195 — TAURUS Posterior Occipital-Cervico-Thoracic Spinal Systems2026-06-02
• K252930 — AQUA Laminoplasty Systems2026-05-27
• K253130 — Dione PEEK Screw System2026-05-27
• K252776 — ARIES Anterior Cervical Plate Systems2026-05-14

Injury

3,163

Malfunction

13,006

Other

2

Total

16,171

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →